CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
HER-2/neu peptide vaccine +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00791037
NCT00791037Phase 2Completed
CompareCT.gov

Phase I/II Study of Adoptive T Cell Therapy Following In Vivo Priming With a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine in Patients With Advanced Stage HER2 Overexpressing Breast Cancer

University of Washington·interventional·Posted Nov 14, 2008·Updated May 25, 2017

In Brief

A Phase 2 clinical trial evaluating HER-2/neu peptide vaccine, leukapheresis, and 4 other interventions for HER2-positive Breast Cancer and 3 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed Summary

This phase I/II trial is studying the side effects of escalating doses of adoptive T cell therapy in treating patients with stage IV breast cancer. Vaccines are given to patient prior the expansion of a person's white blood cells may help the body build an effective immune response to kill tumor cells that overexpress human epidermal growth factor receptor 2 (HER2)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 14, 2008
Enrollment StartOct 1, 2008
Primary CompletionJul 1, 2013
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 17.6 years ago

Interventions

HER-2/neu peptide vaccinebiological

Given ID

leukapheresisprocedure

Undergo leukapheresis

ex vivo-expanded HER2-specific T cellsbiological

Given IV

cyclophosphamidedrug

Given IV

sargramostimbiological

Given ID

laboratory biomarker analysisother

Correlative study